Stem cell company, StemLifeLine of San Carlos is offering to convert the parents? extra embryos into a stem cell line for the family, on the chance that the cells might contribute to a future treatment for one of its members.

Photo: Michael Macor, SFC

Stem cell company, StemLifeLine of San Carlos is offering to...

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stemlifexx_055_mac.jpg Laboratory Manager, Eduardo Caceras works at a Bio Safety Cabinet filling Cell Culture Plates with a nutrient rich medium in which the Stem Cells are grown. StemLifeLine, in San Carlos, a tiny startup is offering to use extra embryos left over from in vitro fertilization procedures to create a stem cell culture for the donor family's future medical needs. Theoretically, the family's cell bank could be used when and if stem cell therapies are developed. No such treatments yet exist. But in theory, the cultures derived by StemLifeLine for individual clients would be a better genetic match for a family member than those of a random donor. Michael Macor / The Chronicle Photo taken on 10/10/07, in San Carlos, CA, USA
Ran on: 10-29-2007
StemLifeLine's laboratory manager Eduardo Caceras fills a cell culture plate with a nutrient rich medium in which stem cells are grown.
Ran on: 10-29-2007 Ran on: 10-29-2007
StemLifeLine's laboratory manager Eduardo Caceras fills a cell culture plate with a nutrient-rich medium in which stem cells are grown.

stemlifexx_095_mac.jpg StemLifeLine CEO, Ana Krtolica retrieving cryo preserved cells from a liquid nitrogen container which is kept at -320 degrees fahrenheit. The bank can hold 1,000 vials which contain the stem cells. StemLifeLine, in San Carlos, a tiny startup is offering to use extra embryos left over from in vitro fertilization procedures to create a stem cell culture for the donor family's future medical needs. Theoretically, the family's cell bank could be used when and if stem cell therapies are developed. No such treatments yet exist. But in theory, the cultures derived by StemLifeLine for individual clients would be a better genetic match for a family member than those of a random donor. Michael Macor / The Chronicle Photo taken on 10/10/07, in San Carlos, CA, USA MANDATORY CREDIT FOR PHOTOG AND SAN FRANCISCO CHRONICLE/NO SALES-MAGS OUT

Photo: Michael Macor

stemlifexx_095_mac.jpg StemLifeLine CEO, Ana Krtolica retrieving...

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stemlifexx_063_mac.jpg A microscopic view of a single living stem cell colony, on a computer screen, surrounded by feeder cells which provides nutrition to the cell as it grows. StemLifeLine, in San Carlos, a tiny startup is offering to use extra embryos left over from in vitro fertilization procedures to create a stem cell culture for the donor family's future medical needs. Theoretically, the family's cell bank could be used when and if stem cell therapies are developed. No such treatments yet exist. But in theory, the cultures derived by StemLifeLine for individual clients would be a better genetic match for a family member than those of a random donor. Michael Macor / The Chronicle Photo taken on 10/10/07, in San Carlos, CA, USA MANDATORY CREDIT FOR PHOTOG AND SAN FRANCISCO CHRONICLE/NO SALES-MAGS OUT

A San Carlos startup is offering to create "personalized" stem cells from the spare embryos of fertility clinic clients on the chance that the cells, frozen and stored away, may some day help a family member benefit from medical breakthroughs.

The novel business plan of StemLifeLine Inc. - which started promoting its service to fertility patients earlier this year as "insurance for the future" - set off a flash fire of protest from stem cell research opponents and supporters alike.

The outcry from anti-abortion groups wasn't surprising. StemLifeLine derives stem cells from very early stage human embryos, which are destroyed in the process. Opponents of the research see this as the moral equivalent of killing a child. This belief is the basis of the Bush administration's limits on federal funding of embryonic stem cell research.

But some of the most fervent denunciations of StemLifeLine came from vigorous supporters of embryonic stem cell research. Two Stanford University critics aired their complaints in newspaper editorial pages. A prominent Stanford ethicist challenged UC San Francisco scientists who are advisers of the company to sever those ties. These critics accuse StemLifeLine of trying to profit from the promise of stem cell research in the present, even though the work may not yield medical treatments for decades, if ever.

StemLifeLine's commercial debut also raised unsettled ethical questions that experts had thought they would consider when therapies actually materialized. The questions can reach deep into the heart of a family's beliefs. Such issues are usually dissected by committees of experts overseeing university stem cell studies involving human embryos, to ensure ethical behavior by the scientists.

But no law dictates how fertility clients may make use of their embryos, and StemLifeLine was legally free to set up shop. As medical research advances, consumers are increasingly facing complex choices in such areas that are not fully regulated, including genetic testing and cord blood banking. As part of the controversial stem cell field, StemLifeLine may present the thorniest example to date.

StemLifeLine chief executive Ana Krtolica said the company arose to help fertility clients who face a difficult decision when they end up with extra embryos after they finish creating their families. The majority of these spare embryos are eventually discarded; a small percentage are given to other infertile couples; and some are donated for research. Clients have asked whether they could personally benefit if their embryos were used to create stem cells, Krtolica said.

StemLifeLine created that option for families willing to bet that stem cell treatments will arise some day. "They feel that way they are preserving something out of the embryos that will have some use in the future," Krtolica said.

Theoretically, stem cells could yield treatment for many illnesses such as diabetes, Alzheimer's disease and spinal cord injuries by providing replacement tissues. Stem cells, which are found throughout the body, are immature cells that can develop into specialized cells that need to be replenished. The most versatile are stem cells derived from human embryos, which can develop into any type of cell such as nerve, heart or skin. StemLifeLine is affiliated with three fertility clinics outside California that explain its service and ship the embryos of interested clients to San Carlos. Patients at other clinics can contact StemLifeLine directly. At its lab on Industrial Road, the company extracts cells from the embryos and converts them into stem cells, which are grown into cultures or "lines" containing millions of cells. The vials of cells are then frozen or "cryopreserved."

StemLifeLine charges as much as $7,000 to create and freeze the stem cell line, and about $350 a year for storage. Additional fees up to $2,000 can be charged by fertility clinics that facilitate the transaction, Krtolica said. The company also offers customers the free option of donating an extra vial of their stem cell cultures for research. Krtolica said about 15 families have participated in pilot studies or as paying customers since the company was founded in 2005. The company does not make clients available for interviews.

Whether StemLifeLine's clients ever benefit hinges on the chance that a stem cell therapy will arise for a specific disease by the time a family member needs treatment for that very illness. In addition, the company that developed the therapy would have to be willing and able to use the family's StemLifeLine cell culture. The chances of all that are remote, say some of the most ardent backers of stem cell research.

Magnus, the Stanford ethicist, said StemLifeLine should tell customers that no stem cell therapy may exist for 30 or 40 years. What's more, he said, the technology may have changed so much a decade from now that the family's stem cells would be unusable. Magnus and other critics also fault StemLifeLine for calling their product "personalized" and "genetically matched" to the family. The cell line would not be an identical genetic match to any family member, they say. It would have a unique assortment of genes from the mother and father, as would a child of the couple. If the cells were transplanted into one of the parents or their children, it's likely that the recipient would still have to take drugs to prevent immune system rejection.

Magnus compares StemLifeLine to the now-defunct Genetic Savings & Clone of Sausalito, which charged fees to store genetic material from beloved pets and planned to make cloned copies for their owners. The outfit folded last year after billing one woman $50,000 for a duplicate feline. Magnus said such companies hype their technologies while offering little of value. He said reputable scientists should dissociate themselves from StemLifeLine.

Those scientists associated with the company include one of the most prominent stem cell researchers in the nation.

Among StemLifeLine's advisory board members is Susan Fisher, who leads UC San Francisco's stem cell program. One of the scientists in Fisher's lab, Olga Genbacev, sits on StemLifeLine's board of directors. The company's staff and boards also include present and former research collaborators of Fisher's.

Fisher defended her ties with StemLifeLine. The company is making high-quality, state-of-the-art cell lines, she said. While they won't be identical genetic matches to any family member, they could be as valuable as a near relation's organ donation for a transplant. With that closer genetic relationship, a stem cell recipient might be able to take lower doses of drugs to suppress immune rejection, Fisher said.

"These stem cell lines are going to be much better genetic matches to the family than some random stem cell line," she said. Fisher said she has no financial interest in the company, and serves on its board free of charge.

Krtolica, a former researcher at Lawrence Berkeley National Laboratory and UC San Francisco, said clients are told that stem cell therapies may not arrive for years. Customers are clearly informed that the stem cells are not clones of any family member, she said. "It goes against everything we believe in to push someone to do this if they don't want it," she said.

The director of Stanford's stem cell program, Renee Reijo Pera, said many of StemLifeLine's customers could lay out a substantial sum and receive nothing. StemLifeLine's Web site states that it has the best chance of creating a stem cell culture if clients have at least 10 spare embryos. Pera said few patients end up with that many.

Krtolica said StemLifeLine will accept clients with fewer than 10 embryos. The client's $5,400 stem cell derivation fee would be returned if the company can't create a culture, she said. An initial $1,200 fee, however, is nonrefundable. Participating fertility clinics would set their own refund policies, Krtolica said. The company declined to provide a copy of its contract.

Pera said embryo-derived stem cells could become irrelevant in future medical care. Scientists at UCSF and other institutions have managed to reprogram adult cells to morph into other cell types. If that work pans out, the patients' own adult cells could be used to create replacement tissues with genes identical to their own.

Genetic matching might not be needed at all under the experimental strategy of the Menlo Park stem cell company Geron, chief executive Thomas Okarma said. The company is trying to create an array of stem cell-derived human cells - such as nerve and skin cells - that will trigger no harmful immune system reactions.

One of StemLifeLine's own advisory board members shares some of the critics' doubts. By the time stem cell therapies are on the market, Food and Drug Administration guidelines for creating the cell cultures may have changed substantially, said Joe Conaghan, director of embryology laboratories at Pacific Fertility Center in San Francisco, which is not formally affiliated with StemLifeLine.

Conaghan and other observers say it might make more sense for families to keep their embryos in a frozen state, and have stem cells made only when therapies actually exist and FDA requirements are known. But Fisher maintains that frozen embryos lose viability over time. Fisher also doubts that stem cell technology will change so much that StemLifeLine's cultures would be useless.

"Personally, if I had a friend going through (in vitro fertilization), I would advise my best friend to do this," she said.

At this point, StemLifeLine's services are offered through three clinics: the Nevada Center for Reproductive Medicine in Reno, its affiliate the Idaho Center for Reproductive Medicine based in Boise, and the Colorado Center for Reproductive Medicine in Denver. Dr. Russell Foulk, director of the Nevada and Idaho clinics, co-founded StemLifeLine.

Foulk said StemLifeLine can ease the often painful quandary of fertility clients who can't decide what to do with spare embryos. "This provides them another opportunity," he said.

Dr. David Adamson, chief executive of the fertility services firm Advanced Reproductive Care in Palo Alto, said he doesn't think many fertility clinics will sign up with StemLifeLine because they could run into legal or ethical snags.

Many clinics follow the voluntary practice guidelines of professional groups such as the American Society for Reproductive Medicine. Adamson, the president-elect of the group, said StemLifeLine's operations would probably be seen as an experiment by committees that set these standards. As subjects of an experiment, StemLifeLine's customers probably should not be charged fees, Adamson said.

Any charges by the fertility clinic would probably be scrutinized by professional societies, he said. "The financial relationship with the clinic and the company would have to be very carefully crafted to protect the best interests of patients," Adamson said.

Pera said she fears some clinics would push the stem cell option on clients as an obligation to protect the family's health. "I worry that people will feel coerced to care for the family in this way," she said.

To head off any such concern, Foulk said his fertility clinics have not charged fees for linking clients to StemLifeLine. Christopher Scott, director of the Stanford program on Stem Cells in Society, wonders whether some individuals might ask fertility clinics to create embryos for the sole purpose of creating a stem cell line, without any intent to conceive a child.

"I certainly wouldn't do it," Foulk said.

Krtolica said none of the clinics currently offering StemLifeLine's services would accept such clients. Doing so would not be illegal, said Robin Alta Charo, a professor of law and medical ethics at the University of Wisconsin-Madison.

But she said the question touches on a major underlying ethical issue that advocates of stem cell research have not previously had to resolve. Supporters of the technology clearly feel it's acceptable to donate an embryo to further medical research - what they see as an altruistic act. But StemLifeLine's activities raise the question: Is it also ethical for parents to create and destroy an embryo in their own self-interest, potentially to save their own or their children's lives?

"It depends on your view of the moral status of an embryo," Charo said. People who see the embryo as a baby would say no. "If you view it as nothing more than a nonsentient collection of cells, like the cells in your liver, you would have no objection. Most people in the United States see it as something in between," Charo said.

Adamson said the complex issues raised by StemLifeLine's operations should be dissected by a panel of 15 to 20 specialists in ethics, religion, economics and medicine who have no conflicts of interest related to the work. "These really important issues have largely been avoided by the government," he said. "These are issues that need to be dealt with."

Stem cell resources

To learn more about StemLifeLine or stem cells in general, here are some resources: